MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. GIBECK TRACH-VENT; HUMID-VENT HEAT AND MOISTURE

Model Number IPN044386

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2022

Event Type  malfunction  

Event Description

It was reported that the trac vent's connector does not fit well to the tracheostomy tube.Due to this it is hard to connect and to disconnect the trac vent from the tracheostomy tube.No injury reported and a new trach vent was used.

Manufacturer Narrative

(b)(4) the device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the trac vent's connector does not fit well to the tracheostomy tube.Due to this it is hard to connect and to disconnect the trac vent from the tracheostomy tube.No injury reported and a new trach vent was used.

Manufacturer Narrative

Qn#(b)(4) five pieces of representative samples were received.The samples were closely examined by visual inspection.No issues were found.The complaint reported that the trac vent's connector does not fit well to the tracheostomy tube.Based on the returned samples provided, 15mm plug gauge test was conducted on the connector of the samples.The connector side is in the specification according to iso 5356-1-2015.In current manufacturing procedure, iqc department will conduct sampling gauge test before release of the part item to production.In production, 100% visual inspection at the assembly area is conducted.Any ineffective products will be culled out during this process.Therefore, it is very unlikely condition at the manufacturing area that the product having defect to be released for shipment.The incident happened may have been due to the defect on the tracheostomy tube.Further study could not be conducted since the tracheostomy tube was not return for investigation.In conclusion, the complaint reported that the trac vent's connector does not fit well to the tracheostomy tube.But as per gauge test conducted on the returned samples, the connector met the specification.Hence, this complaint could not be confirmed.

• Brand Name: GIBECK TRACH-VENT
• Type of Device: HUMID-VENT HEAT AND MOISTURE
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15926628
• MDR Text Key: 305927635
• Report Number: 8040412-2022-00329
• Device Sequence Number: 1
• Product Code: BYD
• UDI-Device Identifier: 44026704348143
• UDI-Public: 04026704348145
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN044386
• Device Catalogue Number: 41112
• Device Lot Number: KMZ22B0572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED